Vestibular Physical Therapy for People With Alzheimer Disease

Alzheimer Disease Clinical Trial

— VPT in AD  

Official title:

Vestibular Physical Therapy for People With Alzheimer Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887923
• Other study ID #: STUDY18120038
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the tolerability and preliminary efficacy of an 8-week home-based vestibular physical therapy program in people with cognitive impairment.

Description:

This project uses a novel non-pharmacological treatment to improve balance and reduce falls in patients with Alzheimer Disease (AD) using a conceptual framework that combines current vestibular physical therapy (VPT) practice guidelines with the latest motor learning theories for cognitively-impaired patients. The modified VPT protocol for AD patients was developed by experts in VPT and motor learning in AD and will be tested. This pilot study will provide much-needed data about whether VPT can be adapted for patients with AD, and whether VPT shows promise in improving or stabilizing balance, spatial cognition, and gait function in patients with AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• mild-AD diagnosis

• complaints or observation of gat disturbance

Exclusion Criteria:

• inability to stand for 3 minutes without rest

• recent lower extremity fractures/severe sprains (within last six months)

• incapacitating back or lower extremity pain

• confounding neurologic or neuromuscular disorders

• presence of benign paroxysmal positional vertigo

• pain elicited during cervical range of motion or limited cervical range of motion

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Vestibular Diseases

Intervention

Behavioral:
• Vestibular Physical Therapy
Balance, Gaze Stabilization, Habituation, and Walking exercises

Locations

Country	Name	City	State
United States	University of Pittsburgh Alzheimer Disease Research Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made	The ability to perform the tasks within VPT will be monitored during each exercise within all eight training sessions. The number of times modifications are needed to be made to the protocol will be recorded (for example, the number of times the participant needs cuing to attend to the exercise for gaze stabilization which requires constant head movement for the 30-second exercise trial will be recorded).	8 weeks
Primary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease; Gait velocity	Gait velocity: preferred walking speed will be recorded over 10-meter distance and is measured in meters/second	10 weeks (the outcomes will be obtained pre- and post-training)
Primary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease: Four Square Step Test	Four Square Step Test: dynamic balance, spatial, & sequencing skills will be assessed as participants step forward, backward, and sideways over a low obstacle and is measured by time (seconds) to complete the test	10 weeks (the outcomes will be obtained pre- and post-training)
Primary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease: Mini Balance Evaluation Systems Test	Mini Balance Evaluation Systems Test: assesses anticipatory postural adjustment, reactive postural control, sensory orientation, and dynamic gait with a total score of 28	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Montreal Cognitive Assessment	Montreal Cognitive Assessment: assesses several cognitive domains and serves as a screening tool for detecting cognitive impairment with scores ranging from 0-30 (score over 26 is considered normal)	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Money Road Map Test	Money Road Map Test assesses egocentric mental rotation in space by recording the total number of errors for right-left discrimination of mental rotation tasks.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Trail Making Test A	Trail Making Test A: assesses executive function by recording the time to accurately connect a sequence of 25 consecutive targets on a sheet of paper.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Trail Making Test B	Trail Making Test B: assesses visual attention and task switching by recording the time to accurately connect a sequence of 25 consecutive targets alternating between numbers and letters on a sheet of paper.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Digit Span Forward & Backward	Digit Span Forward & Backward: assesses memory by recording how many digits the participant can repeat back in the correct order immediately after presentation	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Letter Fluency	Letter Fluency: assesses verbal fluency by recording how many words that the participant can produce that begin with a certain letter in a 60-second timeframe.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Category Fluency	Category Fluency: assesses verbal fluency by recording how many words that the participant can produce that are within a certain category in a 60-second timeframe.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Digit Symbol Substitution	Digit Symbol Substitution assesses cognitive functioning by seeing how many correct digit-symbol pairs the participant can record in 90 seconds using a nine pair options.	10 weeks (the outcomes will be obtained pre- and post-training)
Secondary	Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Benton Visual Retention Test	Benton Visual Retention Test: assesses visual perception and visual memory by asking participants to reproduce 10 different individual designs after a 10-second exposure.	10 weeks (the outcomes will be obtained pre- and post-training)